Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD…

Recall date
March 7, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1317-2018
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
US, Puerto Rico, Malaysia

Why it was recalled

One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

D-RAD Self-Tapping Locking Screw intended for the fixation of fractures involving the distal radius. smith&nephew D-RAD 2.4MM X 10MM S-T LOCKING SCREW, REF 74692410, QTY (1), STERILE R

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